Sun Med Laryngoscope Blades Named in Class I RecallDec 22, 2008 | Parker Waichman LLP
A Class I recall has been issued for laryngoscope blades distributed by Sun Med of Largo, Florida. The Food & Drug Administration (FDA) issues Class I recalls when there is a reasonable probability that the use of a device will cause adverse health consequences or death.
The Sun Med laryngoscope recall involves Greenline/D MacIntosh No. 3 Laryngoscope Blades. The product is labeled "Greenline/D MacIntosh No. 3 Laryngoscope Blades, Sterile and Disposable, Contents 20/box." This recall only involves lot codes Gj and Ha.
According to the FDA recall notice, the blades are part of a medical device (laryngoscope) used to view the vocal cords and other structures when opening a patient’s airway. The laryngoscope blades were recalled because a piece of the acrylic light tube that runs along the laryngoscope blade may break off during procedures.
The FDA said that Sun Med has sent a notice to their distributors requesting that the defective laryngoscope blades be returned. Customers with questions may contact Sun Med at 1-727-530-7099.
Healthcare professionals and consumers may report any problems with the use of the recalled Sun Med laryngoscope blades to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
- Online: www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
- Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
- FAX: 1-800-FDA-0178